Health Trials

Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke

ConditionsIschemic StrokeMotor DeficitsCognitive ImpairmentVagus Nerve Stimulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRheinburg-Klinik

About this trial

The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.

The main questions it aims to answer are:

* Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke? * Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke .

Participants will:

* Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke * Receive smotor and cognitive training during the tVNS or sham stimulation * Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.

Eligibility criteria

Qualifiers

Onset of stroke ≥15 days and ≤30 days after randomization

Ischemic stroke in the anterior cerebral circulation detected by MR imaging or computer tomography

National Institutes of Health Stroke Scale (NIHSS) score ≥3 points

Montreal Cognitive Assessment (MoCA) score ≤ 26 points

Disqualifiers

Age < 18 years

Pregnant and breastfeeding women

Severe concomitant neurological (brain tumor, encephalitis, Parkinson disease, epilepsy prior to stroke onset) or mental disorders (psychiatric conditions such as schizophrenia, uncontrolled depression or bipolar disorder before stroke onset)

Severe aphasia (i.e. unable to follow two-stage-commands)

Trial design

Treatments tested in this trial

  • transcutaneous auricular vagus nerve stimulation
  • sham-stimulation

Treatment groups

144 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Rheinburg Klinik Status unavailable 9824, WalzenenhausenSwitzerlandSwitzerland

Sponsors and collaborators

Rheinburg-Klinik

Lead sponsor

Source ClinicalTrials.gov